What is the mechanism of action of this treatment?

Common treatments for kidney transplantation, such as allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSCs), work primarily through immunomodulation and anti-inflammatory effects. These cells help modulate the immune response, reducing the likelihood of the body rejecting the transplanted kidney. They also decrease inflammation, which can further protect the kidney from damage. For kidney transplant patients, these mechanisms are crucial as they enhance graft survival and function, potentially reducing the need for long-term immunosuppressive therapy and its associated side effects.

What side effects are associated with this type of intervention?

Common treatments for kidney transplant include immunosuppressive therapies such as glucocorticoids, mycophenolate mofetil, and calcineurin inhibitors. These treatments can have side effects including increased risk of infections, hypertension, diabetes, and gastrointestinal issues. Specifically, glucocorticoids can cause serious adverse events like severe infections and hospitalizations, particularly at high doses. Mycophenolate mofetil is generally well-tolerated but can cause gastrointestinal disturbances and bone marrow suppression. Calcineurin inhibitors are associated with nephrotoxicity and neurotoxicity. The investigational use of allo-A-MSCs aims to reduce inflammation and modulate immune responses, but their safety profile is still under study, with potential risks including infection and immune reactions.

What prior FDA approvals exist?

FDA-approved treatments for kidney transplant typically include immunosuppressive drugs to prevent rejection. These include calcineurin inhibitors like tacrolimus and cyclosporine, antiproliferative agents such as mycophenolate mofetil, and mTOR inhibitors like sirolimus. Additionally, corticosteroids like prednisone are often used. While these drugs focus on immunosuppression, the investigational use of allo-A-MSC aims to reduce inflammation and modulate the immune response, potentially offering a novel approach to managing transplant rejection.

What other types of research exist?

Promising alternatives to allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSCs) for kidney transplant patients include bone marrow-derived mesenchymal stromal cells (BM-MSCs) and platelet-rich plasma (PRP). Both have shown immunomodulatory and anti-inflammatory effects that could be beneficial in this context.

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Mesenchymal Stromal Cells

A-MSC Therapy for Kidney Transplant Rejection

Phase 1

Recruiting

Led By Timucin Taner, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if injecting special cells from donated fat tissue into the kidney's main blood vessel can safely reduce inflammation and prevent rejection in patients with transplanted kidneys.

Who is the study for?

This trial is for kidney transplant recipients who can consent, have had a recent biopsy showing rejection, stable renal function with eGFR > 30 ml/min, and specific inflammation or rejection signs in the biopsy. Excluded are those with severe heart conditions, vascular diseases, acute illnesses within 30 days, allergies to contrast agents, unwilling to use contraception for 12 months post-treatment, substance abuse issues, active COVID-19 or other infections like CMV or BK virus.

What is being tested?

The study tests if infusing different doses of adipose-derived mesenchymal stromal cells (A-MSC) into the renal artery can safely reduce inflammation and treat kidney transplant rejection. Participants will receive either a low dose or high dose of A-MSC directly into their transplanted kidney's blood supply.

What are the potential side effects?

Potential side effects may include reactions at the infusion site such as pain or swelling; immune responses leading to fever or fatigue; possible impact on blood pressure and organ function due to inflammatory changes; risk of infection from immunomodulation caused by MSCs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Worsening kidney allograft rejection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low Dose GroupExperimental Treatment1 Intervention

Adult kidney transplant recipients with subclinical rejection (biopsy-proven antibody-mediated and/or cellular rejection, including borderline rejection) will be administered one low dose of allogeneic A-MSC.

Group II: High Dose GroupExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney transplantation, such as allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSCs), work primarily through immunomodulation and anti-inflammatory effects. These cells help modulate the immune response, reducing the likelihood of the body rejecting the transplanted kidney. They also decrease inflammation, which can further protect the kidney from damage. For kidney transplant patients, these mechanisms are crucial as they enhance graft survival and function, potentially reducing the need for long-term immunosuppressive therapy and its associated side effects.

Adipose-Derived Stem/Stromal Cells in Kidney Transplantation: Status Quo and Future Perspectives.The Role of Regulatory Myeloid Cell Therapy in Renal Allograft Rejection.The applications of bone marrow-derived stem cells to induce tolerance and chimerism in organ transplantation.